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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06189300
Other study ID # 5077606250
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date August 1, 2024

Study information

Verified date February 2024
Source Cukurova University
Contact Seyma Yurtseven, Dr.
Phone +9005077606254
Email ssumer01@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study will be conducted on individuals with stoma followed in the stoma therapy outpatient clinic of a university hospital. Based on the f values of the methods to be studied in the literature review, the total sample size found using the GPOWER program with an effect size of 0.4 (Cohen), 90% power and 0.05% margin of error was found to be n = 44. The sample of the research was determined as 52 in this direction. "Informed Consent Form, State-Trait Anxiety Scale, Adaptation Scale for Individuals with Ostomies" will be filled out. Scales will be collected for both groups on postoperative day 1, day 15, and 1 month after surgery. The patients were called by phone on the 7th, 14th and 21st postoperative days and education and counseling services were provided. SPSS package program will be used to analyze the data.


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date August 1, 2024
Est. primary completion date April 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Having undergone stoma surgery in a university hospital, - No vision or hearing problems, - Verbal communication is possible, - Without diagnosed psychiatric problems. Exclusion Criteria: - Want to leave the research

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Education and counseling intervention
In addition to standard training, training and consultancy will be provided to individuals with stoma intermittently within a month.

Locations

Country Name City State
Turkey Cukurova University Adana

Sponsors (1)

Lead Sponsor Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary The effect of education and counseling given to individuals with stoma on complications. Pittman Ostomy Complication Severity Index will be used. This valid and reliable index was developed by Joyce Pittman in 2014 to evaluate the frequency and severity of complications developing in the early postoperative period during the follow-up period of individuals with a stoma. A higher total score indicates more serious ostomy complications. The lowest score that can be obtained from the scale is 0, while the highest score is 92. 1 mounth
Primary The effect of education and counseling given to individuals with stoma on stoma compliance. Ostomy Adjustment Inventory will be used. The lowest score that can be obtained from the scale is 0, while the highest score is 92.This valid and reliable scale was developed to determine the adaptation levels of individuals with stoma. A high score from the scale means that compliance is high. 1 mounth
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